BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 7372468 · Received March 26, 2018

    Report

    Report Number
    2025587-2018-00700
    Event Type
    Death
    Date Received
    March 26, 2018
    Date of Event
    April 8, 2017
    Report Date
    June 7, 2018
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE VALVE SERIAL NUMBER WAS NOT PROVIDED; THUS, A MANUFACTURING/STERILITY REVIEW CANNOT BE PERFORMED. HOWEVER, THE PROCESS USED TO STERILIZE EVOLUTR VALVES HAS BEEN VALIDATED TO MEET THE REQUIREMENTS OF INTERNATIONAL ORGANIZATION FOR STANDARDIZATION 14160. THIS PROCESS RESULTED IN A STERILITY ASSURANCE LEVEL (SAL) OF 10-6, OR THE CHANCE OF AN ORGANISM SURVIVING THE STERILIZATION PROCESS IS ONE IN A MILLION. THE ORGANISM USED TO VALIDATE THE STERILITY ASSURANCE LEVEL WAS CHOSEN AS IT REPRESENTED THE TYPE OF ORGANISM HAVING THE GREATEST RESISTANCE TO THE STERILIZATION PROCESS. THIS WAS DETERMINED THROUGH A SERIES OF CHALLENGE STUDIES USING A WIDE VARIETY OF ORGANISM TYPES. AORTIC REGURGITATION CAN BE CAUSED BY A VARIETY OF FACTORS, INCLUDING VALVE POSITIONING, PATIENT ANATOMY, OR THE PRESENCE OF PRE-EXISTING PATIENT CONDITIONS. THE PATIENT WAS DIAGNOSED WITH ENDOCARDITIS FIVE WEEKS POST IMPLANT, WHICH MAY HAVE CAUSED/CONTRIBUTED TO THE REPORTED SEVERE INSUFFICIENCY. ALTHOUGH THE CAUSATIVE ORGANISM WAS UNABLE TO BE PROVIDED, BIOPROSTHETIC VALVE ENDOCARDITIS OCCURRING EARLY POST-OPERATIVELY, WITHIN SIXTY DAYS, IS USUALLY DUE TO PERIOPERATIVE BACTERIAL CONTAMINATION, AND ARE NOT LIKELY TO BE RELATED TO THE MANUFACTURE OF THE DEVICE. THESE CASES ARE TYPICALLY DUE TO THE INTRODUCTION OF THE MICROORGANISM DURING THE IMPLANT PROCEDURE (1). GIVEN THIS INFORMATION AND THE STERILITY PROCESS, IT IS UNLIKELY THAT THE DEVICE WAS THE SOURCE OF THE REPORTED ENDOCARDITIS OR THE SUBSEQUENT DEATH. (1) MYLONAKIS, E., AND CALDERWOOD, S.B. INFECTIVE ENDOCARDITIS IN ADULTS. NEW ENGLAND JOURNAL OF MEDICINE. 345 (18). 1318-1330. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE PRODUCT REMAINS IMPLANTED; THEREFORE, NO PRODUCT ANALYSIS CAN BE PERFORMED.   CONCLUSION: WITHOUT RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSIONS COULD BE DRAWN REGARDING THE CLINICAL OBSERVATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY FIVE WEEKS AFTER THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, ENDOCARDITIS WITH SEVERE INSUFFICIENCY WAS NOTED. THE PATIENT DIED DUE TO ENDOCARDITIS THREE MONTHS POST IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215299 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-34

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death